This short yet confusing law enacted in 2005 mixes sovereign immunity, product liability and FDA law to provide immunity from liability related to efforts to combat COVID-19. The nuances of the PREP Act—still remain untested in courts—could cause some companies to lose its protections.
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Focus on Health Care Providers
Navigating PREP Act Immunity Webinar
The PREP Act, which can provide immunity from liability for claims related to efforts to combat COVID-19, has achieved mythical status for some in the health care industry. The nuances of this 15-year-old law that remains untested in courts, however, could cause some companies to lose its protections. Join Shook, Hardy & Bacon on a deep-dive into the roots of the PREP Act—a short but confusing law that mixes sovereign immunity, product liability, FDA law and more—and its effects on emergency measures taken by health care providers, practitioners and others in the industry. With Shook’s insight, companies can make informed decisions and implement best practices as they work to combat the novel coronavirus.
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Focus on Life Science
Navigating PREP Act Immunity Webinar
The PREP Act, which can provide immunity from liability for claims related to efforts to combat COVID-19, has achieved mythical status for some in the health care industry. The nuances of this 15-year-old law that remains untested in courts, however, could cause some companies to lose its protections. Join Shook, Hardy & Bacon on a deep-dive into the roots of the PREP Act—a short but confusing law that mixes sovereign immunity, product liability, FDA law and more—and its effects on emergency measures taken by life sciences manufacturers and others in the health care industry. With Shook’s insight, companies can make informed decisions and implement best practices as they work to combat the novel coronavirus.
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Focus on General Manufacturing
Navigating PREP Act Immunity Webinar
The PREP Act, which can provide immunity from liability for claims related to efforts to combat COVID-19, has achieved mythical status for some as they have endeavored to provide products that can help in a global crisis. The nuances of this 15-year-old law that remains untested in courts, however, could cause some companies to lose its protections. Join Shook, Hardy & Bacon on a deep-dive into the roots of the PREP Act—a short but confusing law that mixes sovereign immunity, product liability, FDA law and more—and its effects on companies taking emergency measures to assist during the pandemic. With Shook’s insight, companies can make informed decisions and implement best practices as they work to combat the novel coronavirus.
📎 Additional Resources
- 🔑 PREP Act 101 Infographic
- 🔑 Is Your Product a Covered Countermeasure? Infographic
- 📙 Liability Risks for 3D-Printed Medical Supplies and Protective Products
- 📙 Product Liability Risks for Medical Devices in the UK
- 📙 New Federal Law Extends Existing Tort Protections for Makers of Certain Products Used to Combat COVID-19
FDA Resources:
- General EUA Page
- FDA Guidance on Hand Sanitizer
- FDA Guidance on Face Masks
- FDA EUA for Masks (non-healthcare setting)
PREP Act Declaration and Amendments:
Government Commentary on the PREP Act:
That was a lot.
Do you have questions? We have answers.
Shook attorneys can help you make informed decisions and implement best practices as you work to combat the novel coronavirus. Email our PREP Act Task Force today via the link below.
Want to talk with us instead?
John and Michelle are members of Shook's PREP Act Task Force. Contact them today to get ahead of emerging litigation needs.
John Johnson III
Of Counsel | Washington, D.C.
John works with companies to develop and implement practical and cost-effective solutions for complying with the laws administered by Food and Drug Administration (FDA), U.S. Department of Agriculture (USDA), Customs and Border Protection (CBP) and other federal and state agencies. He works with manufacturers, distributors, brand owners, importers and retailers of food, drugs, medical devices, cosmetics and animal products to satisfy their regulatory obligations.
Michelle Mangrum
Partner | Washington, D.C.
Michelle is a registered nurse and a partner at Shook and with more than 30 years of litigation experience. She has litigated product liability cases in state and federal trial and appellate courts throughout the United States and has defended some of the world’s largest pharmaceutical and medical device manufacturers in product liability and commercial litigation matters.
Credits:
Created with images by National Cancer Institute - "Doctor Holding Cell Phone. Cell phones and other kinds of mobile devices and communications technologies are of increasing importance in the delivery of health care. Photographer Daniel Sone " • Bill Oxford - "untitled image" • David Jorre - "Wavering Curves"